Hatswell Anthony James
BresMed Health Solutions, North Church House, 84 Queen Street, Sheffield S1 2DW, UK and.
Ecancermedicalscience. 2017 Jun 27;11:ed67. doi: 10.3332/ecancer.2017.ed67. eCollection 2017.
As the UK prepares to leave the EU, it must decide what path it is to take with a large number of regulatory and technical agencies who provide collaboration at the European level. In the case of pharmaceuticals, the European Medicines Agency (EMA) provides pan-European licencing for novel pharmaceuticals. Should the UK depart from the EMA system, this article highlights the loss to patients immediately (slower access to novel treatments), and in the long term by having no access to some novel products as companies choose not to launch in the UK. The lack of access then may also preclude the access to these treatments as generic medicines, causing harm far into the future. The other costs considered are the cost for duplicating the functions of the EMA, or the alternative of using the decisions of other regulators without input to decisions made. An alternative is then set out, of how the UK can prosper under 'Brexit', by remaining a member of the EMA, but accepting the decisions without political oversight (as currently happens with the European Commission). Additional freedom could be given to a UK regulator to accept decisions (where appropriate) from other agencies such as the Food & Drug Administration-further speeding access and making the UK a more attractive market. Such an arrangement would put the UK in a better position than the good position it is in currently. This would give patients (both now and in the future) the best access to treatment possible, and promote/attract an industry which employs (directly and indirectly) 500,000 jobs.
随着英国准备脱离欧盟,它必须决定对于众多在欧洲层面提供合作的监管和技术机构要采取何种路径。就制药行业而言,欧洲药品管理局(EMA)为新型药品提供泛欧洲许可。如果英国脱离EMA体系,本文强调这将立即给患者带来损失(获得新型治疗的速度变慢),并且从长远来看,由于公司选择不在英国推出某些新型产品,患者将无法获得这些产品。无法获得这些药品还可能导致无法获得作为仿制药的这些治疗,从而在遥远的未来造成危害。所考虑的其他成本包括重复EMA职能的成本,或者采用其他监管机构的决定而不参与决策过程的成本。然后提出了一种替代方案,即英国如何在“脱欧”情况下繁荣发展,通过继续作为EMA成员,但接受其决定而无需政治监督(就像目前欧盟委员会的情况一样)。可以给予英国监管机构更多自由,使其在适当情况下接受其他机构(如美国食品药品监督管理局)的决定,从而进一步加快药品准入速度,并使英国成为更具吸引力的市场。这样的安排将使英国比目前处于更好的地位。这将为患者(现在和未来)提供尽可能最佳的治疗途径,并促进/吸引一个直接和间接创造50万个就业岗位的行业。